CT-guided Stereotactic Body Radiation Therapy and MRI-guided Stereotactic Body Radiation Therapy for Prostate Cancer, MIRAGE Study

May 7, 2026 updated by: Jonsson Comprehensive Cancer Center

Magnetic Resonance Imaging-Guided Stereotactic Body Radiotherapy for Prostate Cancer (Mirage): A Phase III Randomized Trial

This phase III trial studies compares CT-guided stereotactic body radiation therapy and MRI-guided stereotactic body radiation therapy (SBRT) in treating prostate cancer. Image-guided SBRT is a standard treatment for prostate cancer, which combines imaging of the cancer within the body with the delivery of therapeutic radiation doses produced on a linear accelerator machine. Imaging modalities for image-guided SBRT can be either computed tomography imaging (CT), magnetic resonance imaging (MRI), or a combination of the two. This research is being done to help determine whether there are benefits to MRI-guidance over CT-guidance in patients who are receiving the same radiation dose by SBRT to treat prostate cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVE:

I. To determine whether (MRI)-guided stereotactic body radiotherapy (SBRT) improves acute physician-scored genitourinary (GU) toxicity when compared with standard computed tomography (CT)-guided SBRT for prostate cancer (PCa).

SECONDARY OBJECTIVES:

I. To determine whether there are differences in acute grade >= 2 gastrointestinal (GI) toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale, following MRI-guided SBRT versus CT-guided SBRT.

II. To determine whether there are differences in 5-year cumulative incidences of late grade >= 2 GU and GI physician-reported toxicity, following MRI-guided SBRT versus CT-guided SBRT.

III. To quantify the temporal changes in patient-reported quality of life (QOL) outcomes, as assessed by the Expanded Prostate Cancer Index-26 (EPIC-26), International Prostate Symptom Scores (IPSS), and Sexual Health Inventory for Men (SHIM) QOL indices, following MRI-guided SBRT.

IV. To determine whether there are differences in 5-year biochemical recurrence-free survival (BCRFS) following MRI-guided SBRT.

V. To observe the proportion of SBRT fractions for which on-line adaptive radiotherapy is required due to changes in organ-at-risk anatomy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo 5 fractions of CT-guided SBRT over 14 days in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients undergo 5 fractions of MRI-guided SBRT over 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 4 years, and then yearly thereafter.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
179

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients receiving stereotactic body radiation therapy for the treatment of prostate cancer at the University of California, Los Angeles

Description

Inclusion Criteria:

  • Histologically confirmed, clinical localized adenocarcinoma of the prostate
  • No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)

  • Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping:

    • Low risk: No staging workup required
    • Favorable intermediate-risk: CT abdomen/pelvis if Memorial Sloan Kettering Cancer Center (MSKCC) nomogram predicts >10% probability of lymph node involvement
    • Unfavorable intermediate-risk: technetium bone scan, CT abdomen/pelvis if MSKCC nomogram predicts >10% probability of lymph node involvement
    • High-risk: technetium bone scan, CT abdomen/pelvis if MSKCC nomogram predicts >10% probability of lymph node involvement
    • Advanced imaging studies (i.e. prostate-specific membrane antigen positron emission tomography [PSMA PET] and axumin scan) can supplant a bone scan if performed first
  • Ability to understand, and willingness to sign, the written informed consent

Exclusion Criteria:

  • Patients with neuroendocrine or small cell carcinoma of the prostate
  • Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator
  • Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate
  • Prior pelvic radiotherapy
  • History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia

  • Contraindications to MRI, including:

    • Electronic devices such as pacemakers, defibrillators, deep brain stimulators, cochlear implants;
    • Metallic foreign body in the eye or aneurysm clips in the brain;
    • Severe claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group I (CT-SBRT)
Patients undergo 5 fractions of CT-guided SBRT over 14 days in the absence of disease progression or unacceptable toxicity.
Other: Questionnaire Administration
Ancillary studies
Radiation: CT-guided Stereotactic Body Radiation Therapy
Undergo CT-guided SBRT
Other Names:
  • Computed Tomography-Guided Stereotactic Body Radiation Therapy
  • CT-guided SBRT
Group II (MRI-SBRT)
Patients undergo 5 fractions of MRI-guided SBRT over 14 days in the absence of disease progression or unacceptable toxicity.
Other: Questionnaire Administration
Ancillary studies
Radiation: MRI-guided Stereotactic Body Radiation Therapy
Undergo MRI-guided SBRT
Other Names:
  • MR-guided SBRT
  • Magnetic Resonance Imaging-guided Stereotactic Body Radiation Therapy
  • MRI-guided SBRT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of acute grade >= 2 genitourinary (GU) physician-reported toxicity
Time Frame: 90 days after stereotactic body radiation therapy (SBRT)
Will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale.
90 days after stereotactic body radiation therapy (SBRT)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of acute grade >= 2 gastrointestinal (GI) toxicity
Time Frame: 90 days after SBRT
Will be assessed by the CTCAE version 4.03 scale and rates will be reported descriptively
90 days after SBRT
Incidences of late grade >= 2 GU toxicity
Time Frame: Up to 5 years
Will be assessed by the CTCAE version 4.03 scale and analyzed using a cumulative incidence framework.
Up to 5 years
incidences of late grade >= 2 GI toxicity
Time Frame: Up to 5 years
Will be assessed by the CTCAE version 4.03 scale and analyzed using a cumulative incidence framework.
Up to 5 years
Patient-reported quality of life (QOL) outcomes
Time Frame: Up 5 years
For the Expanded Prostate Cancer Index- 26 (EPIC-26) instrument, these will be represented by changes from baseline in the urinary incontinence, urinary obstruction, bowel, sexual function, and hormone/vitality domains. Changes will be analyzed with respect to whether they represent minimally important differences. For the International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM) instruments, the numerical change from baseline, as well as the raw score at any given timepoint, will be extracted.
Up 5 years
Biochemical recurrence-free survival (BCRFS)
Time Frame: 5 years
Will be estimated using the Kaplan-Meier method as well as descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum)., with biochemical recurrence (BCR) defined as serum PSA levels that are 2 ng/mL higher than the nadir PSA achieved after SBRT.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jonsson Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amar Kishan, UCLA / Jonsson Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-000328
  • NCI-2020-02911 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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